Abstract
The performances of two rapid tests and a standard serological test for the diagnosis of visceral leishmaniasis (VL) were compared using sera from 193 patients with VL and 85 controls. The Kala-Azar Detect(®), IT-LEISH(®) and IFI-LH(®) assays showed sensitivities of 88.1%, 93.3% and 88.6%, respectively, and specificities of 90.6%, 96.5% and 80%, respectively. The sensitivity values were similar for both rapid tests, but the specificity and positive predictive values of IT-LEISH(®) were higher than the corresponding values for IFI-LH(®). Both rapid tests showed satisfactory performances and can be used in primary health care settings; however, IT-LEISH(®) permits the use of whole blood, making this assay more suitable for bedside diagnosis.
Highlights
The performances of two rapid tests and a standard serological test for the diagnosis of visceral leishmaniasis (VL) were compared using sera from 193 patients with VL and 85 controls
In 2008, another rapid test, IT-LEISH® (DiaMed Latino-America SA, Switzerland), was validated through a multicentre study supported by the Brazilian Ministry of Health (MoH)
The purpose of the present study was to compare the performance of the Kala-Azar Detect® assay to the validated IT-LEISH® assay and the immunofluorescence test (IFI-LH®), which is the method routinely used by the National System of Laboratories (IFI-Leishmaniose Humana - Biomanguinhos, Fiocruz, Brazil) for the diagnosis of VL in Brazil
Summary
The performances of two rapid tests and a standard serological test for the diagnosis of visceral leishmaniasis (VL) were compared using sera from 193 patients with VL and 85 controls. In Brazil, the rapid test Kala-Azar Detect® (InBios International, Seattle, WA) was first evaluated in 2003 in 128 VL cases and 50 controls, showing a sensitivity of 90% and a specificity of 100% (Carvalho et al 2003). In 2008, another rapid test, IT-LEISH® (DiaMed Latino-America SA, Switzerland), was validated through a multicentre study supported by the Brazilian Ministry of Health (MoH).
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